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GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study.

Authors :
Dalgaard F
Pieper K
Verheugt F
Camm AJ
Fox KA
Kakkar AK
Pallisgaard JL
Rasmussen PV
Weert HV
Lindhardt TB
Torp-Pedersen C
Gislason GH
Ruwald MH
Harskamp RE
Source :
BMJ open [BMJ Open] 2019 Nov 11; Vol. 9 (11), pp. e033283. Date of Electronic Publication: 2019 Nov 11.
Publication Year :
2019

Abstract

Objectives: To externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.<br />Design: Retrospective cohort study.<br />Setting: Danish nationwide registries.<br />Participants: 90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.<br />Primary and Secondary Outcome Measures: External validation was performed using discrimination and calibration plots. C-statistics were compared with CHA <subscript>2</subscript> DS <subscript>2</subscript> VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.<br />Results: Of the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66-83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA <subscript>2</subscript> DS <subscript>2</subscript> VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).<br />Conclusion: In a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA <subscript>2</subscript> DS <subscript>2</subscript> VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.<br />Competing Interests: Competing interests: KF has received research grants Bayer/Janssen and AstraZeneca and Consulting/Fees Bayer, Sanofi/Regeneron and Verseon. FV has received honoraria for consulting and presentations from Bayer HealthCare, Boehringer Ibgelheimy, BMSPfizer and Daiichi-Sankyo. GHG has ownership of stocks in Novo Nordisk Pharmaceuticals and reports research grants from Pfizer, Bristol Myers Squibb, Boehringer Ingelheim and Bayer. CTP declares grants for studies from Bayer. Other authors have no conflicts of interest to declare.<br /> (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Details

Language :
English
ISSN :
2044-6055
Volume :
9
Issue :
11
Database :
MEDLINE
Journal :
BMJ open
Publication Type :
Academic Journal
Accession number :
31719095
Full Text :
https://doi.org/10.1136/bmjopen-2019-033283